Question 1

Who is the manufacturer of BROOKER FEMORAL NAILS?

Accepted Answer

Biomet Orthopedics, Inc. filed the 510(k) submission for BROOKER FEMORAL NAILS (K002278).

Question 2

What is the FDA product code for BROOKER FEMORAL NAILS?

Accepted Answer

HSB. It is classified under 21 CFR 888.3020 as a Class 2 device in the Orthopedic panel.

Question 3

When was BROOKER FEMORAL NAILS cleared by the FDA?

Accepted Answer

Oct 23, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for BROOKER FEMORAL NAILS?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like BROOKER FEMORAL NAILS?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K002278
Device Name	BROOKER FEMORAL NAILS
Applicant	Biomet Orthopedics, Inc.
Product Code	HSB · Orthopedic
Decision Date	Oct 23, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3020
Device Class	Class 2

BROOKER FEMORAL NAILS

Device Facts

Regulatory Classification

Identification